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Behavioral Intervention

In-Person vs Telehealth Cardiac Rehab for Heart Disease

N/A

Recruiting

Led By Alexis Beatty, MD, MAS

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 or older

Able to communicate in English or Spanish

Must not have

Unable to consent for self

Unstable arrhythmias which may make unmonitored exercise unsafe (e.g., history of ventricular tachycardia not on medical therapy and without an implantable cardioverter defibrillator)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare 2 methods of delivering cardiac rehab: in-person and via telehealth, to see if they have the same effects and who benefits more from one or the other.

Who is the study for?

This trial is for adults over 18 who need cardiac rehabilitation and have had a recent heart-related event or procedure, like a heart attack or surgery. They must be able to attend rehab sessions in-person or via telehealth and communicate in English or Spanish. People with unstable arrhythmias making exercise risky, those deemed unsafe by the investigator, hospice patients, or anyone unable to consent cannot join.

What is being tested?

The study compares two ways of doing cardiac rehab: traditional in-person visits versus remote participation through telehealth. It aims to see if one method is more effective than the other and whether certain patients might benefit more from either approach.

What are the potential side effects?

Cardiac rehabilitation typically doesn't involve medication so it's not associated with typical drug side effects. However, participants may experience physical discomfort from exercise or psychological distress during counseling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can communicate in English or Spanish.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to give my own consent for medical procedures.

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I have heart rhythm problems that make exercise unsafe without monitoring.

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I am not enrolled in hospice care.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in six minute walk distance

Secondary study objectives

Blood pressure control

Change in GAD-7

Change in Generalized Anxiety Disorder (GAD)-7

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: In-person cardiac rehabilitationActive Control1 Intervention

Participants will participate in 12-week in-person cardiac rehabilitation as delivered at the site where they are enrolled. The typical course is 36 sessions of group exercise, health education, and counseling over 12 weeks.

Group II: Telehealth cardiac rehabilitationActive Control1 Intervention

Participants will participate in 12-week telehealth cardiac rehabilitation. The program will follow the same core components as in-person cardiac rehabilitation, but in-person supervised exercise will not be required. The core element of telehealth cardiac rehabilitation is 12 weekly individual telehealth sessions between the patient and cardiac rehabilitation provider.

0 / 5Eligibility criteria met